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17.11.2017 - Pressemitteilung zum ersten Patiententest der nächsten Sensorgeneration (in Englisch)
Successful First-in-Human Testing of Implandata’s Next Generation EYEMATE™ Micro-Sensor for Improved Monitoring of Glaucoma Patients
Friday, 17 November 2017 15:30 (UTC + 1)
Hannover, Germany, November 17, 2017 / B3C newswire / --Implandata Ophthalmic Products GmbH (Implandata) is a privately held, ISO 13485 certified medical device company founded in 2010 in Hannover/Germany. Implandata’s EYEMATE™ system for continuous monitoring of intraocular pressure (IOP) and improved disease care at glaucoma patients is providing vastly improved quality and quantity of information on patient’s IOP, which is key for personalized glaucoma care and therapy control. Remote patient care will increase glaucoma management efficiency, thus contributing to cost savings for all stakeholders. The compelling advantage of the EYEMATE™ system is that measurements can be obtained conveniently at home or at work whenever necessary. There is no need for the patient to have the measurements performed at the doctor’s office.
Implandata now reports that its optimized next generation EYEMATE™ micro-sensor implant for intraocular placement has successfully passed first-in-human validation. Max Ostermeier, CEO of Implandata explains “This opens up the path to proceed forward towards design finalization, expanded clinical validation and regulatory approval. Eventually this will further increase the use of the EYEMATE™ system.”
Successful in-human validation of the miniaturized next generation EYEMATE™ micro-sensor implant represents another pivotal milestone for Implandata. While the current sensor implant requires a surgical incision size of at least 4 mm, the next generation EYEMATE™ micro-sensor device reduces incision size for implantation down to 2.7 mm and less. Prof. Burkhard Dick/Director of the University Eye Hospital of Bochum/Germany, who carried out the first-in-human validation states: “Reduction of incision size is one major advancement, easier insertion and positioning of the micro-sensor another benefit. In eye surgery, less invasive methods mean lower risk of surgical or post-surgical complications, resulting in higher surgeons’ acceptance, also by less experienced ophthalmic surgeons.”
Intraocular pressure (IOP = eye pressure) control is a considerable challenge for glaucoma patients. Current methods for IOP control require in-office measurements, to be performed by trained medical staff. However, these measurements are obtained just a few times each year, even though the eye pressure is known to change throughout the day. In contrast to the sporadic readings obtained in standard clinical practice, the EYEMATE™ system provides actionable IOP readings throughout the day and outside the eye care specialist office, enhancing treatment options and reducing progressive vision loss in glaucoma patients. In addition, as the EYEMATE™ system provides direct feedback to the patient in a home setting - information previously unavailable to the patient - therapy adherence will be improved, as demonstrated in pre-market studies.
The EYEMATE™ system includes a surgically implantable micro-sensor (to be implanted in conjunction with cataract, glaucoma or corneal surgery, ultimately also in a stand-alone procedure) for direct measurement of eye pressure. A patient hand-held device for sensor implant powering and data read-out is communicating real-time via internet with eye care specialists (and the patient as well). Most recently published long-term patient follow-up data confirmed product safety and utility(1).In June 2017, Implandata’s EYEMATE™ system for enhanced monitoring and management of glaucoma patients received European CE mark approval with its current micro-sensor implant. A first European market launch of this product is planned for 2018.